Create CLIA-equivalent certification pathways for non-clinical labs

Research notes

• The RFI text at https://www.govinfo.gov/content/pkg/FR-2026-07-16/html/2026-14358.htm was searched for “non-clinical” (0), “equivalen” (0), “certificate of waiver” (0); “research” appears twice, in boilerplate.
• Queries: Federal Register “CLIA” (32 documents) and “Clinical Laboratory Improvement Amendments” (21) since 2025-01-20; bill titles among those we keep and search, from congress.gov, for CLIA → 0.
• #1295 is the clinical-laboratory scope limb of the same pair and did move to attempted.
• Regulatory agenda, checked 2026-09-01. Checked against the full HHS agenda on reginfo.gov (183 active RINs in the 2026 Unified Agenda, published 2026-08-14), not the abbreviated version the Federal Register prints. The nearest entry is recorded here; it does not name this ask’s object, so the Status is unchanged — an agenda entry that states a general goal in the ask’s subject area does not move the Status.
  • 0938-AV89 (CLIA Virtual Access, Gynecologic Cytology Proficiency Testing, Personnel Qualification Requirements, and Other Changes, CMS-3478, NPRM 09/2026) is the agenda’s only CLIA rulemaking. It modernizes three named areas — virtual access, gynaecologic cytology proficiency testing and personnel qualifications — and proposes no certification-equivalency pathway for non-clinical laboratories or their researchers.